BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE

    MDR report key: 11905771 · Received May 30, 2021

    Report

    Report Number
    3003752502-2021-00007
    Event Type
    Injury
    Date Received
    May 30, 2021
    Date of Event
    May 4, 2021
    Report Date
    October 27, 2021
    Manufacturer
    EUROSETS S.R.L.
    Product Code
    DTZ
    UDI-DI
    08034013782020
    PMA / PMN Number
    K141492
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE PRODUCTION DOCUMENTATION FOR AMG PMP OXYGENATOR, LOT NUMBER 6944908, WAS REVIEWED BY THE EXTERNAL MANUFACTURER (EUROSETS) AND SHOWED THAT ALL TESTS FROM THE PRODUCTION PROCESS WERE COMPLIANT WITH THE TECHNICAL SPECIFICATIONS. THE EUROSETS AMG PMP INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. UNDER THE SECTION TITLED, ¿INTENDED USE¿, THE IFU STATES THAT THE ¿A.M.G. MODULE PMP NO T.P. STERILE IS INTENDED FOR USE IN ADULT SURGICAL PROCEDURES REQUIRING EXTRACORPOREAL GAS EXCHANGE SUPPORT AND BLOOD TEMPERATURE CONTROL FOR PERIODS OF UP TO 6 HOURS¿ AND ALSO THAT THE DEVICE ¿IS INTENDED TO BE USED IN AN EXTRACORPOREAL PERFUSION CIRCUIT TO OXYGENATE AND REMOVE CARBON DIOXIDE FROM THE BLOOD AND TO COOL OR WARM THE BLOOD DURING ROUTINE CARDIOPULMONARY BYPASS PROCEDURES UP TO 6 HOURS IN DURATION. CONTACT WITH BLOOD FOR A LONGER PERIOD OF TIME IS UNADVISABLE.¿ UNDER THE LIST OF PRECAUTIONS, THE IFU CAUTIONS THAT A STRICT ANTICOAGULATION PROTOCOL SHOULD BE FOLLOWED AND ANTICOAGULATION SHOULD BE ROUTINELY MONITORED DURING ALL PROCEDURES. THE BENEFIT OF EXTRACORPOREAL SUPPORT MUST BE WEIGHED AGAINST THE RISK OF SYSTEMIC ANTICOAGULATION AND MUST BE ASSESSED BY THE PRESCRIBING PHYSICIAN. ADEQUATE HEPARINIZATION MUST BE MAINTAINED BEFORE AND DURING BYPASS. UNDER THE LIST OF WARNINGS, THE IFU WARNS THAT DURING THE EXTRACORPOREAL CIRCULATION (ECC) A BACKUP OXYGENATOR IS NECESSARY AND ALSO WARNS THAT THE EXTRACORPOREAL CIRCULATION HAS TO BE CAREFULLY AND CONTINUOUSLY CHECKED. UNDER THE SECTION TITLED, ¿BYPASS START¿, THE IFU CONTAINS A SUBSECTION ON BLOOD GAS MONITORING AND EXPLAINS HOW TO ADJUST THE RELEVANT PARAMETERS BASED ON THE PATIENT¿S BLOOD GAS VALUES. UNDER THE SECTION TITLED ¿OXYGENATOR REPLACEMENT¿, THIS DOCUMENT STATES THAT A SPARE OXYGENATOR MUST ALWAYS BE AVAILABLE DURING PERFUSION. AFTER 6 HOURS OF USE WITH BLOOD OR IF PARTICULAR SITUATIONS OCCUR, WHICH MAY LEAD THE PERSON RESPONSIBLE FOR PERFUSION TO DETERMINE THE SAFETY OF THE PATIENT MAY BE COMPROMISED (INSUFFICIENT OXYGENATOR PERFORMANCE, LEAKS, ABNORMAL BLOOD PARAMETERS, ETC.), FOLLOW THE PROCEDURE OUTLINED IN THE IFU FOR OXYGENATOR REPLACEMENT. INCIDENTAL FINDING: THE EUROSETS EVALUATION REVEALED THAT THE OXYGENATOR WAS CLOTTED. A SPECIFIC CAUSE FOR THE PATIENT "NOT OXYGENATING WELL" COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. THE ANALYSIS OF THE RETURNED OXYGENATOR REVEALED EVIDENCE OF CLOTTING; HOWEVER A DURATION OF TIME FOR WHICH THE CLOTS WERE PRESENT COULD NOT BE DETERMINED, AND A DIRECT CORRELATION BETWEEN THE REPORTED EVENT AND THE OBSERVED CLOTTING COULD NOT CONCLUSIVELY BE DETERMINED. IT WAS REPORTED THAT AFTER 24 HOURS ON A EUROSETS OXYGENATOR, THE PATIENT WAS NOT OXYGENATING WELL AND THE OXYGENATOR WAS SWAPPED TO ANOTHER MANUFACTURER'S DEVICE. IT WAS LATER REPORTED THAT THE PATIENT HAD NO KNOWN ISSUES WITH CLOTTING. THE EUROSETS OXYGENATOR, LOT NUMBER 6944908, WAS RETURNED TO ABBOTT AND AN INITIAL VISUAL INSPECTION WAS PERFORMED. VISUAL INSPECTION OF THE OXYGENATOR REVEALED NO OBVIOUS DAMAGE OR ABNORMALITIES. THE OXYGENATOR WAS FORWARDED TO THE EXTERNAL MANUFACTURER (EUROSETS) FOR TECHNICAL ANALYSIS. THE OXYGENATOR WAS UNABLE TO BE WASHED OR FUNCTIONALLY TESTED DUE TO CLOTTING NOTED IN THE FIBERS. THE PRODUCTION DOCUMENTATION FOR AMG (ADVANCED MEMBRANE GAS EXCHANGE) PMP (POLYMETHYLPENTENE) OXYGENATOR, LOT # 6944908, WAS REVIEWED BY THE EXTERNAL MANUFACTURER (EUROSETS) AND SHOWED THAT ALL TESTS FROM THE PRODUCTION PROCESS WERE COMPLIANT WITH THE TECHNICAL SPECIFICATIONS. THE SPECIFIC ROOT CAUSE FOR INSUFFICIENT GAS EXCHANGE COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, EUROSETS DETERMINED THAT THE ISSUE WAS NOT DIRECTLY RELATED TO THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    THE PATIENT HAD NO KNOWN ISSUES WITH CLOTTING. THE OXYGENATOR WAS REPLACED.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ON A EUROSETS OXYGENATOR. AFTER 24 HOURS PATIENT WAS NOT OXYGENATING WELL, AND THE OXYGENATOR WAS SWAPPED TO A QUADROX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802170 ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE OXYGENATOR, CARDIOPULMONARY BYPASS DTZ EUROSETS S.R.L. US5062 6944908 08034013782020

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention